- Title: Regulatory Affairs Project Leader
- Code: RCI-6443
- Location: Princeton New Jersey (NJ) 08540
- Posted Date: 11/18/2020
- Duration: 6 Months
Talk to our Recruiter
- Name:Sumit Rawat
- Email: email@example.com
- Phone: 908-704-8843 ✖ 232
Top 3 Skills
- 510K submissions
- IVD experience
- Technical background
Bachelor's degree required, Masters degree preferred
Minimum of 6 years experience
- Demonstrated experience clearing devices in US
- Demonstrated ability to work effectively in a team environment. Responsible for writing and timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label/promotional material activities.
- Ability to work constructively, decisively, and collegiality with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs.
- Prior regulatory experience with IVDs or medical devices is required.
- Position is highly visible to internal stakeholders.
- Assists in definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel.
- Communicates issues to management through project management tracking and issue briefings.
- High level of effective verbal and written communication skills must be demonstrated, including ability to negotiate, influence, and manage conflict.
- Experience with CLIA waived products is a plus.
- Ability to communicate effectively in writing crisp briefings and issue analysis.
- Responsible for effective communication of regulatory requirements to project teams and internal customers